AMIODARONE 200 mg Таблетка

Содержание инструкции

1. Amiodarone Aurobindo 200 mg tablets
   1. What is Amiodarone Aurobindo and what it is used for
   2. What you need to know before taking Amiodarone Aurobindo
   3. How to take Amiodarone Aurobindo
   4. Possible side effects
   5. How to store Amiodarone Aurobindo
   6. Contents of the pack and other information

Amiodarone Aurobindo 200 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Amiodarone Aurobindo is and what it is used for
• 2. What you need to know before you take Amiodarone Aurobindo
• 3. How to take Amiodarone Aurobindo
• 4. Possible side effects
• 5. How to store Amiodarone Aurobindo
• 6. Contents of the pack and other information

1. What is Amiodarone Aurobindo and what it is used for

Amiodarone Aurobindo contains a medicine called amiodarone hydrochloride, which belongs to a
group of medicines called antiarrhythmics.
It works by controlling an irregular heartbeat (called “arrhythmia”). Taking the tablets
can help restore the heart rhythm to normal.
Amiodarone can be used for

• Treating an irregular heartbeat when other medicines have not worked or cannot be used.
• Treating a condition in which the heart beats unusually fast (Wolff-Parkinson-White syndrome) when other medicines have not worked or cannot be used. Treating other types of fast or irregular heartbeat known as “atrial flutter” or “atrial fibrillation”. Amiodarone Aurobindo is used only when other medicines cannot be used.
• Treating a rapid heartbeat that can occur suddenly and may also be irregular. Amiodarone Aurobindo is used only when other medicines cannot be used.

2. What you need to know before taking Amiodarone Aurobindo

Do not take Amiodarone Aurobindo

• if you are allergic to iodine, amiodarone or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• if you have a slower than normal heartbeat (called “sinus bradycardia”) or a condition called “sinoatrial block”.
• if you suffer from any other heart rhythm problems and do not have a pacemaker fitted.
• if you have had problems with your thyroid gland. Your doctor will check your thyroid gland before giving you this medicine.
• if you are already taking certain medicines that can affect your heart rhythm (see section “Taking Amiodarone Aurobindo with other medicines” below).
• if you are breastfeeding (see section “Pregnancy and breastfeeding” below).

Do not take this medicine if any of the above apply to you. If you are unsure, ask your doctor or pharmacist before taking Amiodarone Aurobindo.
Warnings and precautions

• if you have heart failure
• if you have liver problems
• if you have lung problems or asthma
• if you suffer from vision problems. These include a condition called “optic neuritis”
• if you are going to have surgery
• if you are an elderly person (over 65 years of age). Your doctor will need to monitor you more closely.
• if you have a “pacemaker” or an “implantable cardioverter defibrillator”. Your doctor will check that the device is working correctly shortly after starting treatment or when the dose is changed.
• With the use of amiodarone, very rare reports of life-threatening skin rashes (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) have been reported. Symptoms may include: flu-like symptoms followed by a widespread painful red or reddish-purple rash and blisters.
• When taking Amiodarone Aurobindo with medicines for hepatitis C such as sofosbuvir, daclatasvir, simeprevir, ledipasvir, cases of severe bradycardia (slow heartbeat), potentially life-threatening, have been reported. Symptoms of bradycardia include dizziness, fainting, shortness of breath, confusion. If you develop any of these symptoms, you should inform your doctor immediately.

If you are not sure if any of the above applies to you, ask your doctor or pharmacist before taking
Amiodarone Aurobindo.

Other medicines and Amiodarone Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines without a prescription, including herbal medicines. This is because it can affect how some other medicines work. Also, some
medicines can affect how amiodarone works.

In particular, do not take this medicine and tell your doctor if you are taking:

• Other medicines for irregular heartbeat (such as sotalol, quinidine, procainamide, disopyramide or bretylium)
• Medicines for infections (such as erythromycin, co-trimoxazole, moxifloxacin or pentamidine, given by injection)
• Medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride or sertindole)
• Medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline)
• Medicines for malaria (such as quinine, mefloquine, chloroquine or halofantrine)
• Medicines used for hay fever, skin rashes or other allergies called antihistamines (such as terfenadine, astemizole or mizolastine)

Tell your doctor if you are taking any of the following medicines:

• medicines that prolong the heartbeat (QT interval) such as medicines for treating infections (such as clarithromycin, ciprofloxacin, ofloxacin or levofloxacin)
• medicines for heart problems called beta-blockers (such as propranolol)
• medicines for treating hepatitis C, a liver disease, such as sofosbuvir, daclatasvir, simeprevir, ledipasvir
• medicines called “calcium channel blockers” - for chest pain (angina) or high blood pressure (such as verapamil or diltiazem)
• medicines for constipation (laxatives), such as bisacodyl or senna
• medicines for high cholesterol (statins), such as simvastatin or atorvastatin

The following medicines can increase the possibility of having side effects when
taken together with Amiodarone Aurobindo:

• amphotericin (when given directly into a vein) - used to treat fungal infections
• medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone
• diuretics
• general anaesthetics or high doses of oxygen - used during surgery
• tetracosactide - used to investigate some hormonal problems

Amiodarone Aurobindo can increase the effect of the following medicines:

• cyclosporine and tacrolimus - used to prevent rejection after a transplant
• medicines used for impotence, such as sildenafil, tadalafil or vardenafil
• fentanyl - used for pain relief
• ergotamine - used for migraine
• midazolam - used to treat anxiety or to help you relax before surgery
• colchicine - used for the treatment of gout
• flecainide - another medicine used for irregular heartbeat. Your doctor will need to monitor the treatment and may halve the dose of flecainide
• lidocaine - used as an anaesthetic
• coumarines - used to prevent blood from clotting
• digitoxin - used for some heart conditions
• dabigatran - used to thin the blood

If you are not sure if any of the above applies to you, ask your doctor or pharmacist before taking
Amiodarone Aurobindo.

Amiodarone Aurobindo with food and drink and alcohol
Do not drink grapefruit juice while taking this medicine because drinking grapefruit juice while
taking Amiodarone Aurobindo can increase the likelihood of having side effects.
You should limit the amount of alcohol during treatment with this medicine. This is because drinking alcohol
while taking this medicine increases the likelihood of having liver problems. Talk to your
doctor or pharmacist about how much alcohol you can drink.

Protect your skin from the sun
Avoid direct sunlight while taking this medicine and for some months after stopping
it. Your skin will be more sensitive to the sun and could burn, sting or blister badly if you do not observe the following precautions:

• make sure you use a sunscreen with a high protection factor
• always wear a hat and clothing that keeps your arms and legs covered

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• Amiodarone Aurobindo is not usually given during pregnancy.
• Do not take Amiodarone Aurobindo if you are breastfeeding or plan to breastfeed as small amounts of this medicine can pass into breast milk.

Driving and using machines
After taking this medicine you may have blurred vision. If this happens, do not drive or
use machines.

Amiodarone Aurobindo contains lactose:If your doctor has told you that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

3. How to take Amiodarone Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor. This will help you to obtain the best results and to reduce the risk of unwanted effects.
Initial dose
The recommended dosage is 200 mg of amiodarone 3 times a day (for a total of 600 mg per
day) for 8-10 days.
Maintenance dose
When the desired effect has been obtained, the dose may be reduced to 100-400 mg (from ½ to 2
tablets of amiodarone 200 mg) per day. Amiodarone 200 mg can be administered once
every 2 days when deemed appropriate (200 mg for 2 days is equivalent to 100 mg per day).
Amiodarone 200 mg tablets should be taken during or immediately after a meal with
water (e.g. a glass).
Use in children and adolescents
The available data regarding efficacy and safety in children are limited. The doctor will establish
the appropriate dose.
The tablet can be divided into two equal doses.

If you take more Amiodarone Aurobindo than you should
If you take more Amiodarone Aurobindo than you should, contact your doctor or go immediately to the
nearest emergency room. Take the medicine packaging with you, so that the doctor knows
what you have taken. The following effects may occur: dizziness, weakness or fatigue, confusion,
slow heartbeat, liver damage and malaise.

If you forget to take Amiodarone Aurobindo
If you forget a dose, take it as soon as you remember. However, if it is almost time for the next dose,
skip the forgotten dose. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Amiodarone Aurobindo
Continue to take Amiodarone Aurobindo until your doctor tells you to stop. Do not stop
taking Amiodarone Aurobindo just because you feel better. If you stop taking this medicine
irregular heartbeats may return. This can be dangerous.

Checks
Your doctor may perform regular checks to verify the functioning of the liver. Amiodarone Aurobindo
can have effects on liver function. If this occurs, the doctor will decide whether you should continue
to take these tablets.
During the intake of this medicine, your doctor may perform regular thyroid checks. In fact
Amiodarone Aurobindo contains iodine which can cause thyroid problems.
Your doctor may also perform other regular checks such as blood tests, chest X-rays, ECG
(electrical test of the heartbeat) and eye examinations before and during treatment with Amiodarone
Aurobindo.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Amiodarone Aurobindo may remain in the blood for up to a month after stopping treatment.
Side effects may still occur during this period.

Stop taking Amiodarone Aurobindo and contact your doctor or go to the hospital immediately if:

• you have an allergic reaction. Signs may include: a skin rash, difficulty swallowing or breathing, swelling of the eyelids, face, lips, throat or tongue.

Common side effects(affect less than 1 in 10 people)

• Yellowing of the skin or eyes (jaundice), feeling tired or unwell, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage, which can be very serious
• Difficulty breathing or a feeling of tightness in the chest, persistent cough, wheezing, weight loss and fever. These symptoms may be due to inflammation of the lungs, which can be very serious.
• Red and itchy skin rash (eczema)

Uncommon side effects(affect less than 1 in 100 people)

• The heartbeat becomes increasingly irregular and unstable. This can lead to a heart attack, so you should go to the hospital immediately.
• Dry mouth

Very rare side effects(affect less than 1 in 10,000 people)

• Loss of vision in one eye or blurred vision and loss of color perception. You may have eye pain and feel pain when you move them. This could be a disease called “optic neuropathy” or “neuritis”.
• The heartbeat becomes very slow or stops. If this happens, go to the hospital immediately.
• Inflammation of the lungs, which can become very serious.

Frequency not known(frequency cannot be estimated based on available data)
Severe allergic reaction (anaphylactic reaction, anaphylactic shock); sudden inflammation of the
pancreas (pancreatitis (acute)); reduced appetite; unusual muscle movements, stiffness, tremor and
restlessness (parkinsonism); abnormal sense of smell (parosmia); confusion (delirium); life-threatening
skin reactions characterized by rash, blisters, skin peeling and pain
(toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute bleeding from the lungs.

Stop taking Amiodarone Aurobindo and go to your doctor immediately if you notice
any of the following side effects – you may need urgent medical attention:
Uncommon side effects(affect less than 1 in 100 people)

• Feeling of numbness or weakness, tingling or burning sensation in any part of the body

Very rare side effects(affect less than 1 in 10,000 people)

• Skin rash caused by narrowing or blockage of blood vessels (called “vasculitis”)
• Headaches may occur (usually worse in the morning or after coughing or stress), feeling unwell (nausea), seizures, fainting, vision problems or confusion. These may be signs of problems in the brain.
• Moving in an unstable or staggering manner, slow and slurred speech
• Feeling faint, dizzy, unusual fatigue and shortness of breath. These may be signs of a slow heartbeat (especially in people over 65 years of age) or other problems with the natural heartbeat. Some cases of bleeding in the lungs have been reported in patients taking Amiodarone Aurobindo. You should inform your doctor immediately if you cough up blood.

Not known

• Chest pain and shortness of breath and irregular heartbeat. These may be signs of a condition called “Torsades de Pointes”

Inform your doctor as soon as possible if you experience any of the following side effects:
Very common side effects(affect more than 1 in 10 people)

• Blurred vision or seeing a colored halo around bright lights

Common side effects(affect less than 1 in 10 people)

• Feeling extremely restless or agitated, weight loss, increased sweating and inability to tolerate heat. These may be signs of a disease called “hyper-thyroidism”
• Feeling extremely tired, weak or debilitated, weight gain, inability to tolerate cold, constipation and muscle pain. These may be signs of a disease called “hypo-thyroidism”
• Trembling when moving arms or legs
• Blue or gray marks on areas of skin exposed to sunlight, especially on the face

Uncommon side effects(affect less than 1 in 100 people)

• Cramps, stiffness or muscle spasms

Very rare side effects(affect less than 1 in 10,000 people)

• Swelling of the testicles
• Red and scaly skin patches, hair loss or brittle nails (called “exfoliative dermatitis”)
• Feeling tired, fainting, dizzy or pale skin. These may be signs of anemia.
• You may bleed and bruise more easily than usual. This may be due to a blood disorder (called “thrombocytopenia”)
• Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be a disease called “inappropriate secretion of the antidiuretic hormone” (SIADH)

Frequency not known(frequency cannot be estimated based on available data)

• Reduced number of white blood cells

Inform your doctor or pharmacist if any of the following side effects worsen or
last more than a few days:
Very common side effects(affect more than 1 in 10 people)

• Feeling sick (nausea) or unwell (vomiting)
• Change in taste
• Change in the amount of liver enzymes at the beginning of treatment, visible in blood tests
• Burning more easily in the sun (see “Protect your skin from the sun” in section 2)

Common side effects(affect less than 1 in 10 people)

• Slightly slowed heartbeat
• Nightmares
• Difficulty sleeping

Very rare side effects(affect less than 1 in 10,000 people)

• Headache
• Balance problems, feeling dizzy (vertigo)
• Difficulty getting or maintaining an erection or ejaculating
• Hair loss, baldness
• Skin rash
• Reddening of the skin during radiotherapy
• Increased creatinine in the blood, shown by blood tests. This may be a sign of impaired kidney function.

Frequency not known(frequency cannot be estimated based on available data)

• Urticaria (itchy rash with bumps)
• Granulomas, small red nodules on the skin or inside the body, visible with X-rays
• Pancreatitis/acute pancreatitis
• Dry mouth
• Anaphylactic reactions
• Reduced appetite
• Parkinsonism
• Parosmia (a disturbance of smell)
• Confusional state, hallucinations
• Reduced libido
• Bullous dermatitis

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Amiodarone Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after
EXP. The expiry date refers to the last day of that month.
Store at a temperature below 30  C
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amiodarone Aurobindo contains

• The active ingredient is amiodarone hydrochloride. Each tablet contains 200 mg of amiodarone hydrochloride.
• The other ingredients are: lactose monohydrate, anhydrous colloidal silica, sodium starch glycolate (type A), povidone (K-30), and magnesium stearate.

Description of the appearance of Amiodarone Aurobindo and contents of the pack
Tablets.
White to off-white, round, biconvex, uncoated tablets, marked with ‘8’ and ‘4’
separated by a score line on one side and ‘A’ on the other side.
Amiodarone Aurobindo tablets are available in blister packs made of opaque white PVC – aluminium foil.

Packs:

Blisters: 10, 20, 30 and 60 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (Varese)

Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000.
Malta
Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD. United
Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: Amiodarone Aurobindo
Portugal: Amiodarona Aurovitas
Spain: Amiodarona Aurovitas 200 mg comprimidos EFG